BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY CRT-D

    MDR report key: 7378503 · Received March 28, 2018

    Report

    Report Number
    2938836-2018-02756
    Event Type
    Death
    Date Received
    March 28, 2018
    Date of Event
    March 27, 2013
    Report Date
    March 28, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z-0116-2017
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDICAL DEVICE REPORT WAS SUBMITTED (2017865 000 2013) LITHIUM CLUSTERS WERE OBSERVED DURING THE ANALYSIS. NO ADDITIONAL ANALYSIS IS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. NO PACING SPIKES WAS SEEN ON THE ECG DESPITE RE-PROGRAMMING. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS SCHEDULED FOR DEVICE CHANGE OUT. SEVERAL DAYS LATER IT WAS REPORTED THAT THE PATIENT DIED DUE TO CIRCUMSTANCES NOT RELATING TO THE ISSUE WITH THE ICD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222408 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC. CD3235-40Q 3168596

    Patients

    Seq Age Sex Outcome Treatment
    1